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OpenTrials
Completed

NCT Number: NCT00797004

Olfactory Dysfunction of Rhinosinusitis

The purpose of this research is to improve understanding of the molecular and functional properties of the human olfactory system.

The specific aims are:

* to determine the location of AC3 and Golf proteins in the human olfactory epithelium from freshly harvested nasal/sinus tissue of surgical patients * to perform objective functional studies on fresh human nasal/sinus tissue using an electro-olfactogram (EOG) whic measures the electrical activity of olfactory sensory neurons in fresh biopsied tissue in response to odor or pheromone stimulation. An organotypic culture system for human tissue has been established to optimize the electrical signal acquisition. * to correlate the AC3 and Golf expression profiles with pre-operative testing of human olfactory function * to correlate the EOG findings with pre-operative testing of human olfactory function. * to systematically evaluate the role of individual intranasal agents on olfaction to further optimize the electrical signal acquisition from olfactory tissue.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Washington Medical Center

Seattle, Washington, 98195, United States

About this study

This is a prospective cohort study. Subjects will be recruited from the group of patients at the University of Washington Otolaryngology-Head and Neck Surgery Clinic who will undergo endoscopic sinus surgery for chronic sinusitis and other disorders of the nasal cavity and sinuses.

Subjects will sign consent and complete a subjective smell test (UPSIT--University of Pennsylvania Smell Identification Test), and the SNOT-20 (Sinonasal Outcome Test-20)

During their surgery, subjects will have two to four pieces of normally discarded tissue preserved for the study. Subjects will also have two to four pieces of healthy tissue removed (total size approximately that of a pencil eraser tip)depending on the type of surgery involved. The following procedures will be performed on these tissues:

  • immunocytochemistry utilizing antibodies to AC3 and Golf to determine the patterns and levels of expression of these proteins
  • two odorants, isoamyl acetate and citralva, to elicit odorant-induced activity from the human olfactory sensory neurons. The tissue will also be subjected to two putative human pheromones: 4,16-androstadiene-3-ol and 1,3,5(10),16-estrateraen-3-ol.
  • application of six commonly used intranasal agents: 0.9% saline, 1:1000,000 epinephrine, 0.05% oxymetazoline, 1% lidocaine, Zicam (0.12% zinc gluconate) and Nasocort AQ (triamcinolone acetate).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • over 18 yrs. of age, scheduled for: a.) endoscopic sinus surgery for chronic sinusitis, b.) endoscopic transnasal approach to the pituitary for pituitary tumor removal, c.) endoscopic inferior turbinectomy for nasal congestion d.)endoscopic repair of cerebrospinal fluid leaks

Exclusion criteria

  • unable to give informed consent or complete questionnaires due to language, cognitive impairment or sever medical conditions.

Sponsors and collaborators

Lead sponsor

Greg Davis

Other

Registry information

Acronym: ODOR

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Nov 24, 2008
Registry last updated
Jun 29, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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